The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...
On 12 April 2013, the Indonesian Capital Investment Coordinating Body (BKPM) issued a new Regulation of the Head of the BKPM No. 5 of 2013 on the Guidelines and Procedures for Permit and Non-Permit Capital Investment (“Reg ...
An expansion strategy doesn’t always need to be M&A driven. Hunton & Williams LLP partners Robert Acosta-Lewis and Susan Failla make the case for strategic alliances. When considering expanding into emerging markets, companies often look to traditional M&A opportunities or explore possible distribution or sales representation relationships. While both of these avenues may offer potential advantages, they also carry risks and limitations ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
The passion Brazilians have for football is nothing new. As children, we learn the game and argue over the rules, which are often anything but black and white and, on occasion, are difficult to apply. That’s true even for referees, who, well into the 21st century, are still barred from employing the full array of technologies available to make their work easier. In contrast to other sports, the rules governing football evolve very slowly ...
Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer. These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
Recently, the United States Supreme Court issued its decision in American Express Co. v. Italian Colors Restaurant, a third opinion in what is now a trilogy of cases upholding the validity of class action waiver clauses in contracts containing arbitration agreements ...
The Federal Trade Commission (FTC) finalized amendments to formally adopt a framework regarding the voluntary withdrawal of Hart Scott Rodino (HSR) premerger notification filings and submission without an additional filing fee to allow additional time for enforcement agency review of transactions during the initial HSR waiting period ...
Decree-Law 2/2005 of 27 December, which approved the Mozambican commercial Code, makes it possible for Mozambican or foreign individuals or clients to set up business in Mozambique in one of six different ways: (i) general partnership (Sociedade em Nome Colectivo); (ii) limited partnership (Sociedade em Comandita); (iii) capital and industry partnership (Sociedade de Capital e Indústria); (iv) quota company (Sociedade por Quotas); (v)
Chambers & Partners has published its Legal Practice Guide on Corporate M&A 2013. The publication, which may be read for free online, includes two Philippine sections contributed by SyCip Salazar Hernandez & Gatmaitan (SyCipLaw): - The section on Philippine Trends and Developments was contributed by Managing Partner Rafael A. Morales and Partner Philbert E. Varona, and contains an overview of the practice, including typical structuring issues and recent developments on foreign ownership ...
In a recent bench ruling, the Delaware Court of Chancery refused to dismiss a stockholder’s complaint alleging, among other things, that a company’s board of directors had amended a stock incentive plan without obtaining stockholder approval as required by the listing rules of the New York Stock Exchange ("NYSE"). The court did so even though the company had received email confirmation from the NYSE staff agreeing that stockholder approval was not required ...
The United States Court of Appeals for the Second Circuit (the "Second Circuit") recently affirmed a broad reading of the safe harbor of United States Bankruptcy Code (the "Bankruptcy Code") section 546(e), which protects from avoidance both "margin payments" and "settlement payments" as well as transfers made in connection with a "securities contract ...
1 Patent Enforcement 1.1 How and before what tribunals can a patent be enforced against an infringer? Patents are enforced against an infringer either through a civil action before the Regional Trial Court (“RTC”) or an administrative action before the Bureau of Legal Affairs (“BLA”) of the Intellectual Property Office of the Philippines (“IPP”) ...
1 Relevant Authorities and Legislation 1.1 What is the relevant Philippine trade mark authority? The Intellectual Property Office of the Philippines (IPOPHIL) is the relevant trade mark authority. 1.2 What is the relevant Philippine trade mark legislation? Republic Act 8293, otherwise known as the Intellectual Property Code of the Philippines (IP Code), is the relevant trade mark legislation. 2 Application for a Trade Mark 2 ...
In Wyeth and Cordis Corp. v. Abbott Laboratories, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants, holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope. (Slip op. at 3) ...
On June 25, 2013, the Consumer Financial Protection Bureau (CFPB or Bureau) issued CFPB Bulletin 2013-06 to announce its "Responsible Business Conduct" policies. The bulletin lays out, in very general terms, suggestions for how companies might curry favor with the Bureau’s Office of Enforcement by engaging in voluntary self-policing, self-reporting, remediation, and cooperation activities. The bulletin is available at [link to http://files.consumerfinance ...
After a prolonged internal debate, the Securities and Exchange Commission has unanimously proposed new rules for the regulation of money market mutual funds, also known as money market funds or money funds. If adopted, these rules would fundamentally change the basic characteristics of most money funds ...
The Commission has adopted, on 11 June 2013, a proposal for a Directive on damages actions for the infringement of EU and national competition laws. If adopted by the EU legislator, the Directive would require the EU Member States to enact implementing legislation within a two year period. Although the groundbreaking features of the proposal make its final adoption uncertain, such adoption would have enormous implications for private competition damages actions within the EU ...
It is known that the effects of better infrastructures on a country’s economy are enormous and this fact has been widely recognised in the ambitious Strategic Development Plan laid down by the Government of East Timor, which highlights that the “policy framework to 2020 will ensure that Timor has quality national infrastructures in place by the end of this decade ...
On June 13, 2013, in the highly anticipated decision for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court shed some light on the future of genetic patenting to companies and scientists working in the personalized medicine and genetics industry. The personalized medicine industry seeks to revolutionize patient care by using genetic sequencing and testing to predict disease likelihood, severity, progression, and/or treatment response ...
Nearly everybody talks about it. The Integrity in Public Contracts Act, also referred to as Bill 1, has been assented to on December 7, 2012 after an expedited review process of barely three months. Everybody is talking about it because the Act imposes on tenderers new requirements aiming at curbing fraud and corruption which, according to investigations of public authorities, undermine the construction industry ...
On June 13, 2013, the Securities and Exchange Commission brought a settled administrative proceeding against Revlon, Inc., for disclosure violations relating to a 2009 exchange offer subject to the going-private rules under Rule 13e-3 of the Securities Exchange Act of 1934.1 As described below, the SEC alleges that Revlon engaged in various acts described as "ring fencing" in an effort to conceal negative information about the transaction from minority stockholders ...
